AI-Powered Global Medical Device Regulatory Support.
Fast - Secure - Powerful
Guaranteed Expert Oversight.
Key Benefits
Accelerated Turnaround
Leverage an AI-assisted workflow to reduce your documentation and submission timelines by up to 50%, getting you to market faster.
Greater Traceability & Quality
Achieve superior consistency across all pillar documentation. Our process ensures a clear, traceable narrative, leading to cleaner, more robust submissions.
Expert-in-the-Loop Guarantee
Benefit from the best of both worlds. While AI handles the heavy lifting, every single output is personally reviewed and verified by a regulatory expert. No exceptions.
Founder Profile
Lisa Donlon
Director & Lead Consultant
I provide security-conscious, AI-assisted regulatory support for Life Science companies. By integrating advanced tools with expert human review, I deliver cleaner submissions and greater traceability, reducing turnaround times by up to 50%. Your project gets the efficiency of AI and the assurance of a seasoned professional.
I also build tools to simplify regulatory challenges. Check out my new EMDN/GMDN and reimbursement information search app. No AI. No sharing your data. Just a usable tool.
Security-First Approach
Your intellectual property is paramount. My workflow is built on a security-conscious framework to ensure your confidential data is always protected.
© Donlon Life Science Consulting Ltd. All rights reserved.
Certainty in a Complex World: Fixed-Price Regulatory Solutions
Navigate the global MedTech landscape with confidence.
Our transparent, fixed-price packages, powered by expert insight and AI-driven efficiency, provide a clear path to market for your medical device or combination product.Bringing an innovative product to market is challenging enough without unpredictable consulting fees. At Donlon Life Science Consulting, we're demystifying the process. Leveraging years of experience as former Notified Body decision-makers and cutting-edge AI integration, we've developed a suite of fixed-price services designed to give you the strategic clarity you need, on budget.
Step 1: The Compass Assessment
Is your product a medical device? A combination product? A consumer good? Before you can create a strategy, you need to know what you're working with. This free, no-obligation assessment provides the foundational clarity you need to move forward.What you get: A concise report detailing the qualification and classification of one device/product family in one target market (e.g., EU or US or Australia or Japan)
Cost: €0 $0 £0
Step 2: The Single-Market Blueprint
With your classification confirmed, this package provides a detailed roadmap for market entry in a single jurisdiction. We'll outline the specific regulatory hurdles, documentation requirements, and timelines you need to anticipate.What you get?
A documented regulatory strategy, including key standards, submission requirements, and a high-level project timeline.Cost: €550 SME / €1000 Enterprise (Nearest approximation at quote date in $ or £)
Step 3: The Global Navigator
Ready to scale? These offering expand your strategy across multiple markets, harmonising requirements where possible and creating an efficient, multi-jurisdictional plan.
Multi-Market Qualification, Classification & Strategy: We'll formally assess and document your product's status across up to 5 key global markets and compile a robust global regulatory strategy that serves as your playbook for international expansion.Cost: €2,275 SME / €3,750 Enterprise
(Nearest approximation at quote date in $ or £)